Opportunities for Emergency Medicine Researchers within the NIH CTSA Program

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Opportunities for Emergency Medicine Researchers
within the NIH CTSA Program

• Roger J. Lewis, MD, PhD
• Harbor-UCLA Medical Center
• Los Angeles Biomedical Research Institute
• David Geffen School of Medicine at UCLA

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Funded CTSA Sites

• Columbia University
• Duke University
• Mayo Clinic
• Oregon Health Sciences University
• Rockefeller University
• University of California, Davis
• University of California, San Francisco
• University of Pennsylvania
• University of Pittsburgh
• University of Rochester
• University of Texas, Houston
• Yale University

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52 Planning Grants

• Brown University
• Children's Research Institute
• Dartmouth College
• Emory University
• Georgetown University
• Harvard University Medical School
• Howard University
• Louisiana State University
• Medical College of Georgia
• Medical College of Wisconsin
• Medical University of South Carolina
• Meharry Medical College
• Methodist Hospital Research Institute
• Michigan State University
• Mount Sinai School of Medicine
• New York University School of Medicine
• Stanford University
• State University New York
• Temple University

• University of Cincinnati
• University of Colorado at Denver and Health
  Sciences Center University of Connecticut School
  of Medicine
• University of Florida
• University of Hawaii at ManoaUniversity of
  Illinois at ChicagoUniversity of Kansas Medical
  CenterUniversity of KentuckyUniversity of
  LouisvilleUniversity of Maryland School of
  MedicineUniversity of Missouri-ColumbiaUniversit
  y of New MexicoUniversity of North Carolina at
  Chapel HillUniversity of North DakotaUniversity
  of Oklahoma Health Sciences Center
• University of South Carolina at
  ColumbiaUniversity of South FloridaUniversity
  of Southern CaliforniaUniversity of Tennessee
  Health Science CenterUniversity of Texas Health
  Science Center At San Antonio
• University of VirginiaUniversity of
  WashingtonUniversity of WisconsinVirginia
  Commonwealth UniversityWake Forest University
  Health SciencesWayne State UniversityWeill
  Medical College of Cornell University

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Key Elements of the CTSA

• Development of Novel Clinical and Translational
  Methodologies
• Pilot and Collaborative Translational and
  Clinical Studies
• Biomedical Informatics
• Design, Biostatistics, and Clinical Research
  Ethics
• Regulatory Knowledge and Support
• Translational Technologies and Resources
• Participant and Clinical Interactions Resources
• Community Engagement
• Research, Education, Training, and Career
  Development

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IOM Recommendations Research

• 8.2a This study should include consideration of
  training of new investigators, development of
  multi-center research networks, funding of
  General Clinical Research Centers (GCRCs) that
  specifically include an emergency and trauma care
  component, involvement of emergency and trauma
  care researchers in the grant review and research
  advisory process, and improved research
  coordination through a dedicated center or
  institute.

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CTSA Sites and Activities

• Sections of applications for 11 of 12 funded CTSA
  sites posted
• Observations from searching those applications
  for the word emergency
• Most occurrences of emergency are related to
  volume of patient visits, not research questions,
  scientific areas of focus, or even locations of
  subject recruitment

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CTSA Sites and Activities

• Finding the word emergency
• Incorporation of emergency and trauma care
  research is highly variable across CTSAs
• Rockefeller no emergency care site
• OHSU high level of integration of emergency care
  activities and investigators

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CTSA ExamplesUniversity of Rochester

• Internal funding application E-cadherin in wound
  healing
• Planned research Biomarkers for mild traumatic
  head injury
• Applying for funds to initiate an emergency care
  research network in upstate New York, from the
  Upstate New York Consortium for Healthcare
  Research and Quality, the Upstate New York
  Translational Research Network, and the
  University of Rochester Clinical and
  Translational Sciences Institute.

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CTSA ExamplesUniversity of Pennsylvania

• Initially, little formal involvement of emergency
  medicine investigators
• Discussing
• Research training/fellowships
• Utilization of CTRC with studies of emergency
  department patients
• Participation in national emergency care sub
  network of CTSAs
• Leveraging data collection programs developed in
  the emergency department

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CTSA ExamplesOregon Health Sciences University

• Department of Emergency Medicine contributed to
  fund for Human Investigation Program (HIP)
• HIP statisticians collaborating with emergency
  care investigators
• Existing Health Systems, Population, and
  Community-based research programs include active
  emergency care research programs and
  investigators
• Funded emergency care investigators serve as
  Oregon CTSI mentors
• Participating in multi-center research consortia

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CTSA ExamplesDuke University

• Initially minimal involvement of emergency and
  trauma care investigators
• Duke Translational Medicine Institute funded
  research ethics project entitled Bridging the
  gap participation in clinical research amongst
  minority populations submitted by emergency care
  investigators

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Training Nomenclature
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Key Opportunities for EM Researchers

• Training programs
• Bring K30, K12, T32 and other research training
  programs into one structure
• Intended to establish translational and clinical
  research as an academic discipline
• Collaborative opportunities
• Access to patients, key populations
• Seed grants
• Support to design, initiate, and gather
  preliminary data

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Training How to Get Involved

• Promising fellows and junior faculty may apply to
  CTSA training programs leading to masters in
  clinical and translational research type degrees
• Theoretical and practical training
• Access and exposure to mentors
• Opportunities for collaboration

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Training How to Get Involved

• Both investigators and research staff may attend
  general research training programs
• Regulatory knowledge
• Practical skills
• CRF design and pilot testing
• Data collection and management
• Adverse event (AE) reporting
• Trial methodology/statistics

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Collaboration Opportunities

• Collaboration on multi- and inter-disciplinary
  research teams
• Participating in clinical research networks
  (access to patients/visits)
• Informing laboratory-based science and first
  phase of translation
• Accelerating second-phase translational and
  clinical trials

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Collaboration Added Value

• Emergency care cuts across
• Populations ethnic, racial, socioeconomic
• Disease categories and severity
• Acute, chronic, and stage of disease
• Emergency care
• Is fundamentally a form of outreach
• May be the best setting to investigate early
  phases of disease (stroke, shock, etc.)

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Collaboration Benefits

• Establish your track record
• Locally
• Publications
• Practical experience and knowledge
• Access to key resources
• Clinical laboratory
• Research laboratories
• Inpatient and outpatient facilities for follow-up
  data collection

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Seed Grants

• CTSAs have internal seed grant programs to
  stimulate exploratory, innovative studies
• Provide resources for acquisition of preliminary
  data
• Allows demonstration of ability to perform
  research and publish results
• Starts a funding track record
• Above are generally required prior to successful
  applications for extramural funding

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Emergency Care ResearchSub-network

• Multiple disease-specific and discipline-specific
  research networks duplicate key infrastructure ?
  Cost effective?
• CTSAs constitute a formal consortium
• Potential to form an emergency care research
  sub-network within CTSAs raised at NIH
• Builds on existing investment in infrastructure
  at each CTSA
• Leverages existing expertise and personnel

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Final Thoughts CTSA Institutions

• Identify and enroll in CTSA training
  opportunities, both masters programs and short
  courses
• Offer to donate effort and access to patients, if
  necessary, to establish collaborations and
  mentor-mentee relationships
• Investigate seed grant programs, if qualified
• Participate in ACEP-SAEM efforts to establish
  CTSA emergency care research network

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Final Thoughts Planning Grant Institutions

• Participate in grant application process,
  offering to help with sections
• Participant and Clinical Interactions Resources
• Community engagement
• Other sections according to expertise
• Identify EM trainees for clinical research
  training, if CTSA is funded
• Plan on possible seed grant applications, if CTSA
  is funded

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